Penile Girth EnhancementNCT07877077
HYAcorp MLF1 Hyaluronic Acid Filler for Penile Girth Enhancement
A study testing cross-linked hyaluronic acid in people with Penile Girth Enhancement, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical trial is to learn how well HYAcorp MLF1, a hyaluronic acid filler, works for penile girth enhancement in men aged 25 years or older. The study will also learn about the safety of the treatment and how long its effect lasts. Read more about this study
- Who is it for?
- Ages 25 years and older, men only
- Conditions the study is for
- Penile Girth Enhancement
- What is being tested?
- cross-linked hyaluronic acid
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male participants aged 25 years or older.
- Seeking penile girth enhancement at the urology clinic.
- Able to understand the study procedures and the potential benefits and risks.
- Able and willing to provide written informed consent.
- Willing to attend the planned follow-up visits at 3, 6, and 12 months.
- No active genital condition identified during the baseline urological examination that would prevent participation in the study.
Who cannot join
- Uncontrolled diabetes mellitus or glycated hemoglobin (HbA1c) greater than 6.5%.
- Active urinary tract infection, genital skin infection, active herpes lesion, or inflammatory skin disease at the treatment site.
- History of penile surgery other than circumcision, including penile prosthesis surgery, reconstructive surgery, or surgery following penile trauma.
- Penile filler treatment within the previous 2 years.
- Congenital or acquired penile abnormality, including Peyronie's disease, micropenis, severe phimosis, or significant penile deformity.
- History of a serious complication related to any previous filler treatment, including soft tissue infection requiring hospitalization or surgery, anaphylaxis, thromboembolic event, necrosis, or severe hypersensitivity reaction.
Show all 12Show fewer
- Known serious allergy to hyaluronic acid, local anesthetics, or planned prophylactic or analgesic medications.
- Coagulopathy, uncontrolled use of anticoagulant or antiplatelet medication, or another clinical condition associated with increased bleeding risk.
- Major systemic disease, advanced immunosuppression, active malignancy, or another clinical condition considered by the investigator to increase the risk of the procedure.
- Suspected body dysmorphic disorder, unrealistic expectations, or severe anxiety or depression requiring psychiatric evaluation.
- Participation in another interventional clinical study within the previous 30 days.
- Social, cognitive, or logistical circumstances that would prevent adherence to the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Biruni University Faculty of Medicine Hospital
Istanbul, Küçükçekmece, 34295
Erdoğan Mete Yalçın, MD, +905326816383, erdogan.mete.yalcin@gmail.com
Gökhan Yazıcı, MD, gokhanyazici@msn.com
About this study
Official title: Evaluation of the Efficacy, Safety, and Durability of Cross-Linked Hyaluronic Acid Body Filler HYAcorp MLF1 for Penile Girth Enhancement
The goal of this clinical trial is to learn how well HYAcorp MLF1, a hyaluronic acid filler, works for penile girth enhancement in men aged 25 years or older. The study will also learn about the safety of the treatment and how long its effect lasts.
The main questions it aims to answer are:
Read more
How much does average flaccid penile circumference change 6 months after treatment? What side effects or medical problems occur after treatment, and how long does the increase in penile girth last?
Participants will:
Receive one treatment with 20 mL of HYAcorp MLF1 Have penile circumference measured before treatment and during follow-up Complete questionnaires about satisfaction and sexual function Attend follow-up assessments for up to 12 months
Read the detailed description
This is a single-center, prospective, single-arm clinical study conducted at Biruni University Hospital. The study will include 65 male participants aged 25 years or older who are seeking penile girth enhancement and meet the eligibility criteria.
After written informed consent and baseline assessment, participants will receive a single 20 mL injection of HYAcorp MLF1, a cross-linked hyaluronic acid filler. The procedure will be performed under sterile conditions and local anesthesia using a blunt-tip cannula. The filler will be placed in the anatomical plane between the dartos fascia and Buck fascia.
Penile circumference will be measured in the flaccid state with the participant lying on his back under standardized conditions. Measurements will be taken at the distal, middle, and proximal penile shaft. The average of these three measurements will be used as the study measurement. Follow-up measurements will be performed by a clinician who did not perform the injection and who will not have access to procedural details.
The primary outcome is the change in average flaccid penile circumference from baseline to 6 months after treatment. Other assessments will include penile circumference at additional follow-up visits, participant-reported durability of the filler effect, satisfaction, erectile function, ejaculatory function, and safety.
Participants will be assessed shortly after the procedure, at approximately 7 and 30 days for safety, and at 3, 6, and 12 months for clinical follow-up. Adverse events will be recorded throughout the study. New participant enrollment will be temporarily stopped if a serious treatment-related or unexpected safety concern is identified.
- Conditions
- Penile Girth Enhancement
- Being tested
- cross-linked hyaluronic acid
- Keywords
- Hyaluronic Acid Filler, HYAcorp MLF1, Penile Augmentation, Penile Circumference, Dermal Filler
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cross-linked hyaluronic acidDevice
Also called HYAcorp MLF1
Participants will receive a single 20 mL injection of HYAcorp MLF1, a cross-linked hyaluronic acid filler, under sterile conditions and local anesthesia. The filler will be administered using a blunt-tip cannula into the anatomical plane between the dartos fascia and Buck fascia, with the aim of achieving a homogeneous increase in penile girth.
| Study group | Role | What they receive |
|---|---|---|
| HYAcorp MLF1 | Experimental | Participants will receive a single 20 mL treatment with HYAcorp MLF1 for penile girth enhancement and will be followed for 12 months. Receives: Device: cross-linked hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Average Flaccid Penile Circumference at Month 6
Flaccid penile circumference will be measured in millimeters at the distal, middle, and proximal penile shaft using a non-stretch measuring tape under standardized conditions. The arithmetic mean of the three measurements will be recorded as the average flaccid penile circumference. Change will be calculated as the Month 6 value minus the baseline value.
Measured: Baseline and Month 6
Secondary outcomes (10)
Change From Baseline in Average Flaccid Penile Circumference at Other Follow-up Time Points
Average flaccid penile circumference will be calculated as the arithmetic mean of distal, middle, and proximal shaft circumference measurements. Change at each follow-up time point will be calculated as the follow-up value minus the baseline value and reported in millimeters.
Measured: Baseline, immediately after treatment, Month 3, and Month 12
Participant-Reported Residual Filler Durability Score
Participants will estimate the amount of residual filler using a 5-level ordinal scale: 0=no residual filler, 1=approximately 25% remaining, 2=approximately 50% remaining, 3=approximately 75% remaining, and 4=approximately 100% remaining. Higher scores indicate greater perceived filler durability.
Measured: Month 3, Month 6, and Month 12
Change From Baseline in Penile Appearance Satisfaction Score
Penile appearance satisfaction will be rated on a 5-point ordinal scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied. Higher scores indicate greater satisfaction. Change will be calculated as the follow-up score minus the baseline score.
Measured: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in Sexual Life Satisfaction Score
Sexual life satisfaction will be rated on a 5-point ordinal scale: 1=very dissatisfied, 2=dissatisfied, 3=neutral, 4=satisfied, and 5=very satisfied. Higher scores indicate greater satisfaction. Change will be calculated as the follow-up score minus the baseline score.
Measured: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
Erectile function will be assessed using the validated 5-item International Index of Erectile Function (IIEF-5). The total score ranges from 5 to 25, with higher scores indicating better erectile function and therefore a better outcome. Change from baseline will be calculated as the follow-up score minus the baseline score.
Measured: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
Ejaculatory function will be assessed using the validated 5-item Premature Ejaculation Diagnostic Tool (PEDT). Total scores range from 0 to 20, with higher scores indicating a greater likelihood or severity of premature ejaculation. Change will be calculated as the follow-up score minus the baseline score.
Measured: Baseline, Month 3, Month 6, and Month 12
Number of Participants With Adverse Events Through Month 12
Adverse events will be recorded according to onset, severity, relationship to treatment, and outcome. The number and proportion of participants experiencing adverse events will be summarized. Serious adverse events will be reported separately and described narratively.
Measured: From treatment through Month 12
Inter-rater Reliability of Penile Circumference Measurements Assessed by Intraclass Correlation Coefficient
Agreement between two independent evaluators will be assessed using a two-way random-effects, absolute-agreement intraclass correlation coefficient [ICC(2,1)] with a 95% confidence interval.
Measured: Month 12
Proportion of Participants Lost to Follow-up by Month 12
The number and proportion of enrolled participants who do not complete the planned follow-up through Month 12 will be reported.
Measured: From enrollment through Month 12
Proportion of Participants Without Major Protocol Deviations
Protocol adherence will be assessed as the proportion of participants who complete the study without a major protocol deviation. The protocol-compliant analysis set will include participants without major protocol deviations.
Measured: From enrollment through Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Penile Girth EnhancementStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Barış Nuhoğlu, Biruni University
- Investigators
- Barış Nuhoğlu, MD, Principal investigator, Biruni University Faculty of Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877077
- Sponsor's protocol ID
- BIRUNI-URO-MLF1-2026-01
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because this study did not include a prespecified plan or mechanism for external sharing of de-identified participant-level data. Study findings will be reported in aggregate form.
Publications
Zucchi A, Scroppo FI, Capogrosso P, Salonia A, Duante J, Bini V, Liguori G, Bartoletti R. Clinical use of hyaluronic acid in andrology: A review. Andrology. 2022 Jan;10(1):42-50. doi: 10.1111/andr.13083. Epub 2021 Aug 2.
PubMed 34297894Le Penske W, Leslie DC, Latini JM, Lerner LB. Injectable Penile Enhancement Procedures: A Review of Agents, Risks, and Complications. Urology. 2024 Jul;189:126-134. doi: 10.1016/j.urology.2024.05.013. Epub 2024 May 20.
PubMed 38777188Quan Y, Gao ZR, Dai X, Kuang L, Zhang M, Li Q, Xu T, Zhang XW. Complications and management of penile augmentation with hyaluronic acid injection. Asian J Androl. 2021 Jul-Aug;23(4):392-395. doi: 10.4103/aja.aja_78_20.
PubMed 33533738Kusumaputra A, Setiawan MR, Soebadi MA, Wirjopranoto S. Efficacy and complications of hyaluronic acid and polylactic acid for penile augmentation: a systematic review and meta-analysis. Ann Med Surg (Lond). 2023 Jul 22;85(9):4531-4538. doi: 10.1097/MS9.0000000000001094. eCollection 2023 Sep.
PubMed 37663705Ahn ST, Shim JS, Bae WJ, Kim SW, Kim JJ, Moon DG. Efficacy and Safety of Penile Girth Enhancement Using Hyaluronic Acid Filler and the Clinical Impact on Ejaculation: A Multi-Center, Patient/Evaluator-Blinded, Randomized Active-Controlled Trial. World J Mens Health. 2022 Apr;40(2):299-307. doi: 10.5534/wjmh.210007. Epub 2021 May 7.
PubMed 33988002Yang DY, Jeong HC, Ko K, Lee SH, Lee YG, Lee WK. Comparison of Clinical Outcomes between Hyaluronic and Polylactic Acid Filler Injections for Penile Augmentation in Men Reporting a Small Penis: A Multicenter, Patient-Blinded/Evaluator-Blinded, Non-Inferiority, Randomized Comparative Trial with 18 Months of Follow-up. J Clin Med. 2020 Apr 5;9(4):1024. doi: 10.3390/jcm9041024.
PubMed 32260508Yang DY, Jeong HC, Ahn ST, Bae WJ, Moon DG, Kim SW, Lee WK. A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial. J Sex Med. 2020 Jan;17(1):133-141. doi: 10.1016/j.jsxm.2019.10.006. Epub 2019 Nov 15.
PubMed 31735613Yang DY, Ko K, Lee SH, Lee WK. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med. 2019 Apr;16(4):577-585. doi: 10.1016/j.jsxm.2019.01.310. Epub 2019 Mar 2.
PubMed 30833149
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy, Safety, and Durability of Cross-Linked Hyaluronic Acid Body Filler HYAcorp MLF1 for Penile Girth Enhancement
- ClinicalTrials.gov ID
- NCT07877077
- Acronym / sponsor ID
- BIRUNI-URO-MLF1-2026-01
- Conditions
- Penile Girth Enhancement
- Keywords
- Hyaluronic Acid Filler, HYAcorp MLF1, Penile Augmentation, Penile Circumference, Dermal Filler
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn how well HYAcorp MLF1, a hyaluronic acid filler, works for penile girth enhancement in men aged 25 years or older. The study will also learn about the safety of the treatment and how long its effect lasts.
The main questions it aims to answer are:
How much does average flaccid penile circumference change 6 months after treatment? What side effects or medical problems occur after treatment, and how long does the increase in penile girth last?
Participants will:
Receive one treatment with 20 mL of HYAcorp MLF1 Have penile circumference measured before treatment and during follow-up Complete questionnaires about satisfaction and sexual function Attend follow-up assessments for up to 12 months
Detailed description
This is a single-center, prospective, single-arm clinical study conducted at Biruni University Hospital. The study will include 65 male participants aged 25 years or older who are seeking penile girth enhancement and meet the eligibility criteria.
After written informed consent and baseline assessment, participants will receive a single 20 mL injection of HYAcorp MLF1, a cross-linked hyaluronic acid filler. The procedure will be performed under sterile conditions and local anesthesia using a blunt-tip cannula. The filler will be placed in the anatomical plane between the dartos fascia and Buck fascia.
Penile circumference will be measured in the flaccid state with the participant lying on his back under standardized conditions. Measurements will be taken at the distal, middle, and proximal penile shaft. The average of these three measurements will be used as the study measurement. Follow-up measurements will be performed by a clinician who did not perform the injection and who will not have access to procedural details.
The primary outcome is the change in average flaccid penile circumference from baseline to 6 months after treatment. Other assessments will include penile circumference at additional follow-up visits, participant-reported durability of the filler effect, satisfaction, erectile function, ejaculatory function, and safety.
Participants will be assessed shortly after the procedure, at approximately 7 and 30 days for safety, and at 3, 6, and 12 months for clinical follow-up. Adverse events will be recorded throughout the study. New participant enrollment will be temporarily stopped if a serious treatment-related or unexpected safety concern is identified.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HYAcorp MLF1 | Experimental | Device: cross-linked hyaluronic acidParticipants will receive a single 20 mL treatment with HYAcorp MLF1 for penile girth enhancement and will be followed for 12 months. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male participants aged 25 years or older.
- Seeking penile girth enhancement at the urology clinic.
- Able to understand the study procedures and the potential benefits and risks.
- Able and willing to provide written informed consent.
- Willing to attend the planned follow-up visits at 3, 6, and 12 months.
Key exclusion criteria (12 listed)
- Uncontrolled diabetes mellitus or glycated hemoglobin (HbA1c) greater than 6.5%.
- Active urinary tract infection, genital skin infection, active herpes lesion, or inflammatory skin disease at the treatment site.
- History of penile surgery other than circumcision, including penile prosthesis surgery, reconstructive surgery, or surgery following penile trauma.
- Penile filler treatment within the previous 2 years.
- Congenital or acquired penile abnormality, including Peyronie's disease, micropenis, severe phimosis, or significant penile deformity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cross-linked hyaluronic acidAlso: HYAcorp MLF1Participants will receive a single 20 mL injection of HYAcorp MLF1, a cross-linked hyaluronic acid filler, under sterile conditions and local anesthesia. The filler will be administered using a blunt-tip cannula into the anatomical plane between the dartos fascia and Buck fascia, with the aim of achieving a homogeneous increase in penile girth. | Device | HYAcorp MLF1 |
Primary outcome
Change From Baseline in Average Flaccid Penile Circumference at Month 6
Time frame: Baseline and Month 6
Flaccid penile circumference will be measured in millimeters at the distal, middle, and proximal penile shaft using a non-stretch measuring tape under standardized conditions. The arithmetic mean of the three measurements will be recorded as the average flaccid penile circumference. Change will be calculated as the Month 6 value minus the baseline value.
10 secondary outcomes
Change From Baseline in Average Flaccid Penile Circumference at Other Follow-up Time Points
Time frame: Baseline, immediately after treatment, Month 3, and Month 12
Participant-Reported Residual Filler Durability Score
Time frame: Month 3, Month 6, and Month 12
Change From Baseline in Penile Appearance Satisfaction Score
Time frame: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in Sexual Life Satisfaction Score
Time frame: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in International Index of Erectile Function-5 (IIEF-5) Score
Time frame: Baseline, Month 3, Month 6, and Month 12
Change From Baseline in Premature Ejaculation Diagnostic Tool (PEDT) Score
Time frame: Baseline, Month 3, Month 6, and Month 12
Number of Participants With Adverse Events Through Month 12
Time frame: From treatment through Month 12
Inter-rater Reliability of Penile Circumference Measurements Assessed by Intraclass Correlation Coefficient
Time frame: Month 12
Proportion of Participants Lost to Follow-up by Month 12
Time frame: From enrollment through Month 12
Proportion of Participants Without Major Protocol Deviations
Time frame: From enrollment through Month 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 34297894Zucchi A, Scroppo FI, Capogrosso P, Salonia A, Duante J, Bini V, Liguori G, Bartoletti R. Clinical use of hyaluronic acid in andrology: A review. Andrology. 2022 Jan;10(1):42-50. doi: 10.1111/andr.13083. Epub 2021 Aug 2.
- Background: PubMed 38777188Le Penske W, Leslie DC, Latini JM, Lerner LB. Injectable Penile Enhancement Procedures: A Review of Agents, Risks, and Complications. Urology. 2024 Jul;189:126-134. doi: 10.1016/j.urology.2024.05.013. Epub 2024 May 20.
- Background: PubMed 33533738Quan Y, Gao ZR, Dai X, Kuang L, Zhang M, Li Q, Xu T, Zhang XW. Complications and management of penile augmentation with hyaluronic acid injection. Asian J Androl. 2021 Jul-Aug;23(4):392-395. doi: 10.4103/aja.aja_78_20.
- Background: PubMed 37663705Kusumaputra A, Setiawan MR, Soebadi MA, Wirjopranoto S. Efficacy and complications of hyaluronic acid and polylactic acid for penile augmentation: a systematic review and meta-analysis. Ann Med Surg (Lond). 2023 Jul 22;85(9):4531-4538. doi: 10.1097/MS9.0000000000001094. eCollection 2023 Sep.
- Background: PubMed 33988002Ahn ST, Shim JS, Bae WJ, Kim SW, Kim JJ, Moon DG. Efficacy and Safety of Penile Girth Enhancement Using Hyaluronic Acid Filler and the Clinical Impact on Ejaculation: A Multi-Center, Patient/Evaluator-Blinded, Randomized Active-Controlled Trial. World J Mens Health. 2022 Apr;40(2):299-307. doi: 10.5534/wjmh.210007. Epub 2021 May 7.
- Background: PubMed 32260508Yang DY, Jeong HC, Ko K, Lee SH, Lee YG, Lee WK. Comparison of Clinical Outcomes between Hyaluronic and Polylactic Acid Filler Injections for Penile Augmentation in Men Reporting a Small Penis: A Multicenter, Patient-Blinded/Evaluator-Blinded, Non-Inferiority, Randomized Comparative Trial with 18 Months of Follow-up. J Clin Med. 2020 Apr 5;9(4):1024. doi: 10.3390/jcm9041024.
- Background: PubMed 31735613Yang DY, Jeong HC, Ahn ST, Bae WJ, Moon DG, Kim SW, Lee WK. A Comparison Between Hyaluronic Acid and Polylactic Acid Filler Injections for Temporary Penile Augmentation in Patients with Small Penis Syndrome: A Multicenter, Patient/Evaluator-Blind, Comparative, Randomized Trial. J Sex Med. 2020 Jan;17(1):133-141. doi: 10.1016/j.jsxm.2019.10.006. Epub 2019 Nov 15.
- Background: PubMed 30833149Yang DY, Ko K, Lee SH, Lee WK. A Comparison of the Efficacy and Safety Between Hyaluronic Acid and Polylactic Acid Filler Injection in Penile Augmentation: A Multicenter, Patient/Evaluator-Blinded, Randomized Trial. J Sex Med. 2019 Apr;16(4):577-585. doi: 10.1016/j.jsxm.2019.01.310. Epub 2019 Mar 2.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because this study did not include a prespecified plan or mechanism for external sharing of de-identified participant-level data. Study findings will be reported in aggregate form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Barış Nuhoğlu, MD principal investigator
Biruni University Faculty of Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cross-linked hyaluronic acid in people with Penile Girth Enhancement, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erdoğan Mete Yalçın, MD (+905326816383, erdogan.mete.yalcin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Average Flaccid Penile Circumference at Month 6 (time frame: Baseline and Month 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07877077, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.